ACTIN FSL ACTIVATED PTT REAGENT
Device Facts
| Record ID | K863594 |
|---|---|
| Device Name | ACTIN FSL ACTIVATED PTT REAGENT |
| Applicant | American Dade |
| Product Code | GGW · Hematology |
| Decision Date | Oct 17, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
